Biomaterial Database

Changing requirements for evaluation of pharmacologic agents. 2004

Russell W Chesney, and Michael L Christensen

Department of Pediatrics, Center for Pediatric Pharmacokinetics and Therapeutics, University of Tennessee, Memphis, USA. rchesney@utmem.edu

Children sadly have been excluded from some of the therapeutic advances that have marked pharmaceutical drug development during the past 100 years. Most drugs in use today lack Food and Drug Administration approval for use in children or are restricted to certain pediatric age groups, predominantly older than 12 years. Only a few of the new drugs approved each year have pediatric indications and dosing guidelines described in the drug labeling information. However, many of these drugs are used in children. The lack of suitable information places children at risk for over- or underdosing, and there is a lack of suitable dosage forms, which can result in improper drug administration. This lack of information on the safe and effective use of drugs in the most vulnerable patients--infants and neonates--is of greatest concern. Recent changes in the regulations that govern drug development has dramatically increased the number of drugs that undergo testing in children. This article reviews new laws that govern drug testing in children and the use of children in therapeutic research.

UI	MeSH Term	Description	Entries
D007223	Infant	A child between 1 and 23 months of age.	Infants
D007880	Legislation, Drug	Laws concerned with manufacturing, dispensing, and marketing of drugs.	Drug Laws,Food, Drug and Cosmetic Act,Narcotic Laws,Drug Legislation,Drug Law,Law, Drug,Law, Narcotic,Laws, Drug,Laws, Narcotic,Narcotic Law
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D017277	Drug Approval	Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.	Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval
D049673	History, 20th Century	Time period from 1901 through 2000 of the common era.	20th Century History,20th Cent. History (Medicine),20th Cent. History of Medicine,20th Cent. Medicine,Historical Events, 20th Century,History of Medicine, 20th Cent.,History, Twentieth Century,Medical History, 20th Cent.,Medicine, 20th Cent.,20th Cent. Histories (Medicine),20th Century Histories,Cent. Histories, 20th (Medicine),Cent. History, 20th (Medicine),Century Histories, 20th,Century Histories, Twentieth,Century History, 20th,Century History, Twentieth,Histories, 20th Cent. (Medicine),Histories, 20th Century,Histories, Twentieth Century,History, 20th Cent. (Medicine),Twentieth Century Histories,Twentieth Century History